Accurate Norovirus Detection within 1hr - CE IVD Marked

Cepheid have released the Xpert® Norovirus, a qualitative in vitro diagnostic test for rapid identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII), to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid's GeneXpert® System.

"Norovirus exposure is an unfortunate fact of life. The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults. To actively manage the infection, clinicians have been forced to choose between accuracy and time-to-result when selecting a testing method — but now Xpert Norovirus delivers both," said John Bishop, Cepheid's Chairman and Chief Executive Officer.

Noroviruses are divided into five genogroups, GI to GV. Xpert Norovirus detects and differentiates the GI and GII genogroups, which account for the majority of human infections.

"In the hospital setting, patients admitted with severe Norovirus infection can be a source of this infection to other patients," said Dr. Kate Templeton, Honorary Senior Lecturer in Medical Microbiology at the University of Edinburgh, and a Consultant Clinical Scientist in Microbiology. "It is important that patients infected with Norovirus are identified as early as possible. Rapid molecular testing, when combined with prompt infection control measures of infected patients, provides an important new weapon in our battle against healthcare associated infections."

"Xpert Norovirus is the first test of its type to provide STAT molecular detection of this emerging nosocomial pathogen," said Dr. David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Norovirus outbreaks require immediate implementation of infection control procedures and this new test gives clinicians accurate results in as little as one hour."